An interventional study of Monovisc in Osteoarthritis Ankle, sponsored by Anika Therapeutics, Inc.. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Anika Therapeutics, Inc. · Not applicable, Interventional, and Treatment
Among 71 studies in Osteoarthritis with a site in Poland — 11 open to participants now, 12 under way, none of them phase 3. Osteoarthritis · Poland.
Among the 71 studies in Osteoarthritis with a site in Poland, this one is the 59th largest by enrollment of the 64 interventional ones, is one of 3 that started in 2019, is one of 24 with no phase, and was the 35th registered.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →11 of the 71 studies in Osteoarthritis with a site in Poland are open now, in 12 countries. Each count lists the studies.
Of the 287 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 72 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →71 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2019.
Median enrollment 121 across the 64 interventional studies, 130 across the 7 observational. Of the 52 that completed or were terminated, 25 (48%) have results posted.
47 of 71 have an industry lead sponsor. The 10 most frequent:
Anika Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Anika Therapeutics, Inc. has 7 studies filed under Osteoarthritis — fewer than ten, so there is no comparison to draw.
3 of the studies in Osteoarthritis with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06833749KeyBioscience AGEfficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis | 2026-11 |
| NCT07474896Poznan University of Medical SciencesDiaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery | 2027-01-01 |
| NCT07580716Enlivex Therapeutics Ltd.Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis | 2027-02 |
Among the 71 studies in Osteoarthritis with a site in Poland, from their registry updates:
Nothing recorded among them since 2026-09-25.
The goal of this study is to demonstrate the clinical improvement and safety in patients treated with MONOVISC for ankle osteoarthritis. Specifically, this study will provide confirmation to the effectiveness and safety of MONOVISC at relieving ankle joint pain to 6 months post-treatment.
Obtain real world, post market data to confirm the clinical improvement and safety in patients treated with a single injection of MONOVISC for the symptomatic relief of osteoarthritis in the ankle joint. The entire study duration from first subject in to last subject out will be approximately one and half years. The enrollment phase will be approximately 12 months with a follow-up phase of 6 months. Visits will be scheduled at screening, baseline, 1 month, 3 months and 6 months post treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single injection of MONOVISC into the index ankle joint
Device: Monovisc
A chemically cross-linked sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe.
Numerical Rating Scale (NRS) Pain on Walking
Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Ankle from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
Time frame: Baseline to 6 Months
American Orthopaedic Foot and Ankle Society (AOFAS) Score
Mean Change from baseline to 6 months in the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System Score. AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information in three parts to evaluate Pain, Function and Alignment. Patients report their pain (40 points), and function (50 points), and the evaluator assesses alignment (10 points). A total score is calculated by adding the three scores for final range from 0 (worst clinical status) to 100 points (best clinical status). A positive increase in value for the change in AOFAS score indicates improvement. A larger positive value indicates a higher level of improvement, and a better outcome.
Time frame: Baseline to 6 Months
Patient Global Assessment (PGA) Score
Mean change from baseline to 6 months in ankle pain post-treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) ankle is bothering them today. The PGA Score is a validated 11-point Likert scale from 0=No Pain to 10=Worst Pain. A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
Time frame: Baseline to 6 Months
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function \>50% and an absolute change \>20 mm; or (2) improvement of \>20% with an absolute change \>10 mm in at least of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome.
Time frame: 6 Months
Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)
The usage of Rescue Medication (RM) as based on the number of participants at 6 months post treatment that were NOT using acetaminophen/paracetamol RM for pain or discomfort. A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.
Time frame: 6 Months
| Milestone | Monovisc |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Ankle from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
| score on a scale | Monovisc |
|---|---|
| Numerical Rating Scale (NRS) Pain on Walking | -3.00 ± 1.80 |
Mean Change from baseline to 6 months in the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System Score. AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information in three parts to evaluate Pain, Function and Alignment. Patients report their pain (40 points), and function (50 points), and the evaluator assesses alignment (10 points). A total score is calculated by adding the three scores for final range from 0 (worst clinical status) to 100 points (best clinical status). A positive increase in value for the change in AOFAS score indicates improvement. A larger positive value indicates a higher level of improvement, and a better outcome.
| score on a scale | Monovisc |
|---|---|
| American Orthopaedic Foot and Ankle Society (AOFAS) Score | 16.08 ± 13.27 |
Mean change from baseline to 6 months in ankle pain post-treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) ankle is bothering them today. The PGA Score is a validated 11-point Likert scale from 0=No Pain to 10=Worst Pain. A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
| score on a scale | Monovisc |
|---|---|
| Patient Global Assessment (PGA) Score | -2.96 ± 1.97 |
The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function \>50% and an absolute change \>20 mm; or (2) improvement of \>20% with an absolute change \>10 mm in at least of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome.
| Participants | Monovisc |
|---|---|
| The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | 21 |
The usage of Rescue Medication (RM) as based on the number of participants at 6 months post treatment that were NOT using acetaminophen/paracetamol RM for pain or discomfort. A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.
| Participants | Monovisc |
|---|---|
| Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol) | 20 |
Collected over Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 Months).. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Monovisc | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| Event | Monovisc |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/25 |
| Abdominal painGastrointestinal disorders | 1/25 |
| PharyngitisInfections and infestations | 1/25 |
| Urinary tract infectionInfections and infestations | 1/25 |
Single injection of MONOVISC into the Index Ankle
| Age, Continuous(years) | MONOVISC |
|---|---|
| Mean | 52.16 ± 14.26 |
| Sex: Female, Male(Participants) | MONOVISC |
|---|---|
| Female | 13 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | MONOVISC |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 25 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Index Ankle(Participants) | MONOVISC |
|---|---|
| Right | 13 |
| Left | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2019 to primary completion in Feb 2021, 14 months.
Results were first posted in Jan 2025, 3 years 11 months after primary completion.
Of 135 industry-sponsored interventional studies with no phase under Osteoarthritis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 81. This study's 14 months is below that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Anika Therapeutics, Inc.